Needleless valve infection prevention and pre-opening device

ABSTRACT

A disinfecting and pre-opening device is disclosed for use with a female needleless connector. The disinfecting and pre-opening device includes a housing comprising a chamber having a distal opening and configured to fit over the female needleless connector, and an elongated finger attached to the housing and disposed within the chamber such that the elongated finger opens the fluid path through the female needleless connector when the distal opening of the disinfecting and pre-opening device is placed proximally adjacent to the septum and the disinfecting and pre-opening device is advanced in the distal direction.

FIELD

This application is a continuation of U.S. application Ser. No.14/275,810 entitled “NEEDLELESS VALVE INFECTION PREVENTION ANDPRE-OPENING DEVICE,” filed on May 12, 2014, which is a continuation ofU.S. application Ser. No. 12/841,959 entitled “NEEDLELESS VALVEINFECTION PREVENTION AND PRE-OPENING DEVICE,” filed Jul. 22, 2010, andissued as U.S. Pat. No. 8,721,627, all of which are hereby incorporatedby reference in their entirety for all pruposes.

BACKGROUND

Many healthcare facilities have converted to needleless intravenous (IV)infusion systems to reduce the risk of injury to the healthcareprovider. The infusion sets that are used as part of a needlelessinfusion system frequently have access ports so that additionalmedications can be administered without disconnecting the tubing fromthe IV pump or IV fluid container. One such needleless system uses Luerfittings to connect fluid components together, with the female Luerconnector that may incorporate an elastomeric septum having a slit or apiston. When a syringe or other fluid container that is fitted with amale Luer connector is mated to the female Luer connector of the accessport, the male Luer tip penetrates through the slit in the septum ordisplaces the piston to establish a fluid path between the connectors.

Needleless connectors in an IV system must be sterile prior to themating of the two connectors to prevent bacteria or other microorganismsfrom being carried by the IV fluid into the bloodstream of the patient.While the access port is sterile when removed from its package, it isexposed to the open air while in use and can possibly be contaminatedshortly after it is removed from the package. It is a common protocol tosterilize the surface of the septum of the access port by wiping theseptum with a disinfectant such as isopropyl alcohol immediately priorto mating a male Luer connector to the access port. This requires thehealthcare provider to have alcohol wipes on hand and, if they do nothave any wipes or swabs available when they are about to connect a fluidcontainer to the access port, they must stop and return to the supplycabinet to gather more alcohol wipes. This takes up valuable time andcreates a risk of this sterilization step being skipped.

Healthcare providers occasionally experience difficulty in connecting amale Luer fitting to a female Luer connector having a pre-slit septum.The tip of the male Luer fitting may not entirely penetrate the slit andthe septum deforms without creating a fluid path. In such cases, theconnectors must be separated and reconnected, which creates anopportunity for contamination of the connector surfaces and is notclinically recommended. In some cases, the slit will not fully open andthe healthcare provider must replace the infusion set having the failedaccess port, which consumes the healthcare provider's time and may causediscomfort for the patient as well as present additional risk ofinfection or sympathetic flow.

Accordingly, there is a need for a device and method that increases theprobabilities that an exposed surface of a female Luer connector isdisinfected prior to mating connectors and that the pre-slit septum willproperly mate with a male Luer fitting.

SUMMARY

The disclosed device enables healthcare providers to sterilize theexternal surface of a pre-slit septum in a female Luer connector andpre-opens the slit to ensure that a proper fluid path is establishedduring the first access when a male Luer connector is mated to thefemale Luer connector.

A disinfecting and pre-opening device is disclosed for use with a femaleneedleless connector. The disinfecting and pre-opening device includes ahousing comprising a chamber having a distal opening and configured tofit over the female needleless connector, and an elongated fingerattached to the housing and disposed within the chamber such that theelongated finger opens the fluid path through the female needlelessconnector when the distal opening of the disinfecting and pre-openingdevice is placed proximally adjacent to the septum and the disinfectingand pre-opening device is advanced in the distal direction.

In another embodiment, a disinfecting and pre-opening system for usewith a female needleless connector is disclosed. The disinfecting andpre-opening system includes a fluid delivery appliance having a maleneedleless connector; and a disinfecting and pre-opening deviceremovably coupled to the male needleless connector of the fluid deliveryappliance. The disinfecting and pre-opening device includes a housingcomprising a chamber configured to fit over the female needlelessconnector, a disinfectant disposed within the chamber, and an elongatedfinger attached to the housing and disposed within the chamber such thatthe elongated finger opens the fluid path through the female needlelessconnector when the distal opening of the disinfecting and pre-openingdevice is placed proximally adjacent to the septum and the disinfectingand pre-opening device is advanced in the distal direction.

In another embodiment, a method of disinfecting and pre-opening a femaleneedleless connector, and connecting a fluid delivery appliance having amale needleless connector to the female needleless connector isdisclosed. The method includes the steps of removing a portion of a lidthat is removably sealed across a distal opening of a chamber of adisinfecting and pre-opening device, wherein the chamber is configuredto fit over the female needleless connector and the chamber contains adisinfectant and a finger, placing the distal opening of thedisinfecting and pre-opening device proximally adjacent to the septum ofthe female needleless connector and advancing the disinfecting and preopening device in the distal direction until the disinfectant contactsthe surface of the septum and the finger opens the fluid path throughthe female needleless connector, removing the disinfecting andpre-opening device from the female needleless connector, and mating themale needleless connector of the fluid delivery appliance to the femaleneedleless connector.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1 illustrates an example prior art IV infusion system.

FIG. 2 is an enlarged view of a prior art female Luer access port ofFIG. 1 having a pre-slit septum.

FIGS. 3A-3B illustrate a prior art process of connecting a male Luerconnector to a female Luer connector having a pre-slit septum.

FIG. 3C illustrates one possible failure mode in a prior art process ofconnecting a male Luer connector to a female Luer connector having apre-slit septum.

FIGS. 3D-3E illustrate a prior art process of connecting a male Luerconnector to a female Luer connector having a piston with a pre-cutslit.

FIG. 3F illustrates one possible failure mode in a prior art process ofconnecting a male Luer connector to a female Luer connector having apiston with a pre-cut slit.

FIGS. 4A-4D illustrate a disinfecting and pre-opening device accordingto certain embodiments of the present disclosure.

FIGS. 5A-5D illustrate a disinfecting and pre-opening device accordingto certain other embodiments of the present disclosure.

FIG. 6 illustrates a disinfecting and pre-opening device configured as aseparate item according to certain aspects of the present disclosure.

FIG. 7 illustrates a disinfecting and pre-opening device configured toincorporate a Luer cap according to certain embodiments of the presentdisclosure.

FIGS. 8A-8D depict an example sequence of use of a disinfecting andpre-opening device according to certain embodiments of the presentdisclosure.

FIG. 9 is a flow chart that illustrates an exemplary method of using adisinfecting and pre-opening device according to certain embodiments ofthe present disclosure.

DETAILED DESCRIPTION

Bloodstream infections acquired while undergoing medical treatmentpresent a serious risk to patients. The connectors in an infusion systemthat are exposed to the open air for a period of time prior to aconnection being made from a fluid source are a potential source ofinfection, as any bacteria that have accumulated on the surface of theconnector may be carried directly into the blood stream by the fluidpassing through the connector. While it is a common protocol tosterilize the external surface of the connector prior with an alcoholwipe prior to connecting a fluid source, this step may be ineffective ifperformed incorrectly or may be skipped altogether in somecircumstances. One approach to ensuring that a connector is sterilizedprior to use is to provide a convenient device that enables thehealthcare provider to easily complete an effective sterilization.

Failure to be able to mate a male Luer fitting to a female Luer accessport having a pre-slit septum that is part of an IV set may requireeither disconnection and reconnection of the connector fittings orpossibly replacement of the entire IV set, both of which present anadditional risk of infection to the patient. The causes of a pre-slitseptum failing to accept a male Luer fitting may include cross-linkingof elastomeric components, such as the two sides of a slit in aelastomeric septum or between a piston and the surrounding housing,during the sterilization process during manufacture, failure of thefactory-applied lubricant to satisfactorily penetrate the slit of theseptum or between the piston and housing, and roughness of the surfaceof the male Luer tip of the mating connector. One approach toeliminating these sources of failure is to pre-open the fluid path ofthe female needleless connector during disinfection and prior toconnecting a fluid delivery appliance such as a syringe or IV tubingconnected to an IV fluid bag. This breaks any cross-link bonds betweenportions of the female needleless connector and carries the lubricantthat is on the surface down into the slit or between the piston andhousing.

Certain exemplary embodiments of the present disclosure include a devicethat disinfects and pre-opens a female needleless connector. The devicemay be provided as a separate item or as an accessory that can beattached to a male Luer fitting of a fluid delivery appliance.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure.

FIG. 1 illustrates an example prior art IV infusion system 12. Theinfusion system 12 incorporates a flexible IV bag 14 connected throughIV set 18, which includes the lines and fittings within the dashed line,to an infusion pump 16 and then to a patient 10. The fluid in the IV bag14 may be a saline solution or a solution containing one or moremedications. If an additional medication must be administered, such as amedication to alleviate pain, it is undesirable to either disconnect anyportion of the current IV set 18 or to start a new infusion line as bothpresent an additional risk of infection. The example infusion set 18includes an access port 20 having a needleless connector so that theadditional medication may be administered through the existing IV set 18without disconnecting any portion of the IV set 18.

FIG. 2 is an enlarged view of a prior art female Luer access port 20 ofFIG. 1 having a pre-slit septum. The access port 20 has a housing 21with external threads 22 so that a male Luer fitting (not shown) may besecurely and removably connected to the access port 20. The septum 24is, in this example, an elastomeric plug that is mounted flush with theexternal surface at one end of the access port 20 to eliminate featuresthat are difficult to sterilize. The septum 24 has a central slit 26through the thickness of the septum 24. The slit 26 is normally closedand fluid-tight when not connected to another Luer connector. Otherconfigurations of access slits, such as an “X” shaped cross-cut, as wellas other types of needleless connectors incorporating other types ofseals, such as pistons, are also used in practice.

FIGS. 3A and 3B are cross-sectional views depicting a male Luerconnector 30 and a female Luer connector 40 before and after making aneedleless Luer connection, respectively. In the illustrated example,the male Luer connector 30 includes a housing 34 having a first Luerscrew thread 36 formed therein. The male Luer connector 30 furtherincludes a male Luer tip 32 having a cannula 38. In the illustratedexample, the male Luer connector 30 is a part of a syringe 100, but inother embodiments, the male Luer connector may be connected to a fluidsource (e.g., an IV bag), IV tubing, or other fluid delivery appliance.The female Luer connector 40 has an elastomeric septum 44 with a slit46, shown as a line through the thickness of septum 44 in thiscross-section view. The housing of connector 40 incorporates threads 42that will be engaged by threaded sleeve 34 of connector 30. FIG. 3Billustrates the configuration of a successfully mated pair of Luerconnectors 30 and 40, wherein the male Luer tip 32 has penetratedthrough slit 46 and the threaded sleeve 34 is engaged with the threads42 of the female Luer connector. In this configuration, there is a fluidpath from connector 30 to connector 40 through the male Luer tip 32.

FIG. 3C illustrates one possible failure mode in connecting a male Luerconnector 30 to a female Luer connector 40. The male Luer tip 32 has notpenetrated slit 46 and there is no fluid path from connector 30 toconnector 40. This failure may be due to the elastomeric material ofseptum 44 having cross-linked across slit 46 during the sterilizationprocess during manufacture and the blunt shape of male Luer tip 32 isnot effective in breaking this cross-linked bond. Another possible causeof this failure may be that the material of male Luer tip 32 is notsliding when in contact with the surface of septum 44 due to a lack oflubricant or the roughness of the male Luer tip 32.

FIGS. 3D-3E illustrate a prior art process of connecting a male Luerconnector 30 to a female Luer connector 90 having a piston 47 with apre-cut slit 46. FIG. 3D illustrates a portion of the piston 47 whichhas a flat upper surface that is flush with the end of body 41 of FIG.3A and a collapsible body within the female Luer connector 90. FIG. 3Eillustrates the configuration of a successfully mated pair of Luerconnectors 30 and 90, wherein the male Luer tip 32 has pushed the piston47 into the body of Luer connector 90, whereupon slit 46 opens, and thethreaded sleeve 34 is engaged with the threads 42 of the female Luerconnector. In this configuration, there is a fluid path from connector30 to connector 90 through the male Luer tip 32 and slit 46.

In other configurations of female Luer connectors having pistons, thepiston may not have a slit 46 and may form a fluid path by deformationof the piston 47 that opens a fluid path between the side wall of maleLuer tip 32 and piston 47. In other configurations, the surface ofpiston 47 may be shaped so as to provide gaps between male Luer tip 32and the surface of piston 47 over a portion of the circumference of maleLuer tip 32.

FIG. 3F illustrates one possible failure mode in a prior art process ofconnecting a male Luer connector to a female Luer connector 90 having apiston 47 with a pre-cut slit 46. In this example, piston 47 has bondedto the housing 41, preventing the piston from moving down into the widerregion 45 where slit 46 opens. Slit 46 may also be cross-linked, furtherobstructing the flow path through the female Luer connector 90.

FIGS. 4A-4D illustrate a disinfecting and pre-opening device 50according to certain embodiments of the present disclosure. As shown inFIG. 4A, device 50 is a separate item that is applied to the female Luerconnector 40 prior to mating the male Luer connector 30 of FIG. 3A. Thedisinfecting and pre-opening device 50 comprises a housing 52 having achamber 53 of a diameter sufficient to encompass the width of the femaleLuer connector 40. The chamber 53 is formed from a circumferentialsidewall 55 and a proximal wall 57. Threads 54 are formed on the innerwall of circumferential sidewall 55 and are of the proper size and shapeto engage the threads 42 of the female Luer connector 40. Within thechamber 53 is a matrix 56 that is configured to retain a quantity of adisinfectant fluid such as, for example and without limitation,isopropyl alcohol or chlorhexadine. The matrix 56 can be anyfluid-absorbing material such as, for example and without limitation,polyester, polyvinyl acetate, polyurethane, or cotton, and may be formedinto a woven or nonwoven pad or a foam. In certain embodiments, thematrix 56 is at least partially attached (e.g., glued) to an insidesurface of the chamber 53 to prevent movement of the matrix 56 duringuse. Device 50 also incorporates a central finger 58 sized such that thetip will fully penetrate the septum of most female Luer connectors. Inthis example, finger 58 has a rounded tip and a tapered shaft and aheight that is less than the height of housing 52 such that finger 58will not contact a surface placed across the distal opening of housing52 thereby avoiding contamination. The female Luer connector 40 has aseptum 44 mounted to the proximal end of body 41, septum 44 having aproximal surface 48 and a slit 46, shown in this view as dividing theseptum 44 into two pieces although septum 44 is a single element whenviewed in perpendicular directions. Surface 48 may have a coating oflubricant (not shown) that was applied at the time of manufacture.Threads 42 are formed on the external wall of body 41 and conform, inthis example, to the generally accepted Luer dimensions.

FIG. 4B illustrates the position of device 50 after it has been matedwith female Luer connector 40 and rotated until the matrix 56 is seatedagainst the surface 48 of septum 44. Contact with or compression ofmatrix 56 may release a portion of the liquid disinfectant to wet thesurface 48 as well as the portions of the body 41 adjacent to surface48. At the same time, finger 58 has penetrated slit 46, carryinglubricant from surface 48 into slit 46. Additionally, disinfectantreleased from matrix 56 may infiltrate the slit 46 along the side offinger 58. The rotation of the device 50 as the matrix 56 comes intocontact with surface 48 may additionally provide a scrubbing action thatmay assist in the cleaning and disinfection of surface 48.

FIG. 4C illustrates the position of device 50 after it has been matedwith female Luer connector 90 and rotated until the matrix 56 is seatedagainst the surface 48 of piston 47. Contact with or compression ofmatrix 56 may release a portion of the liquid disinfectant to wet thesurface 48 as well as the portions of the body 41 adjacent to surface48. At the same time, finger 58 has displaced piston 47, allowinglubricant to coat the surface of body 41 formerly in contact with theside of piston 47, and penetrated slit 46, carrying lubricant fromsurface 48 into slit 46. Additionally, disinfectant released from matrix56 may infiltrate the slit 46 along the side of finger 58.

FIG.4D illustrates the position of device 50 after it has been matedwith a female Luer connector 91 that comprises a piston 49 that does nothave a slit, wherein the flow path through the female Luer connector 91is between housing 41 and the outside of piston 49. Finger 58 hasdisplaced piston 49 to break any cross-links between the piston 49 andthe housing 41 and open the fluid path through female Luer connector 91.Disinfectant released from matrix 56 may flow down and onto the surface51 of piston 49, or disinfection of surface 51 may be performed as aseparate operation.

FIGS. 5A-5D illustrate configurations of a disinfecting and pre-openingdevice according to certain other embodiments of the present disclosure.FIG. 5A illustrates a device 50 wherein housing 52 has a smooth interiorwall 60 such that the device is applied to female Luer connector 40 ofFIG. 4B by sliding rather than screwing device 50 onto the threads 42 offemale Luer connector 40. FIG. 5B shows a device 50 having a lining 62of an elastomeric material located on the wall of chamber 53 and sizedsuch that the sleeve 62 contacts the threads 42 or external wall of body41 such that the device 50 is removably retained on female Luerconnector 40. Lining 62 may be a coating on the wall of chamber 53 or aseparate sleeve that is inserted into the chamber 53. FIG. 4C disclosesa configuration wherein the matrix 56 is formed such that a portion 64of matrix 56 coats a portion of the inner wall of chamber 53 and asecond portion 65 coats a portion of finger 58. In this example, matrix56 does not cover the tip of finger 58 although other configurations maycover the entire surface of finger 58. FIG. 5D illustrates aconfiguration wherein the matrix 56 has a portion 66 that coats aportion of the smooth inner wall of chamber 53 and a portion 68 thatcoats a portion of finger 58 wherein finger 58 is undercut where portion68 terminates.

FIG. 6 illustrates a disinfecting and pre-opening device configured as aseparate item according to certain embodiments of the presentdisclosure. Certain features depicted in FIG. 6 can be employed with anyof the embodiments of FIGS. 4a -4B and FIGS. 5A-5D. In this example, thecircumferential sidewall 55 is a tapered cylinder. In certainembodiments, the circumferential sidewall 55 may be configured as asquare, a hexagon, or other shape with or without a taper. There is aproximal wall (not visible in this view) that is attached and sealed tothe circumferential side wall 55 around the entire circumference of thecircumferential side wall 55 along the proximal edge of thecircumferential side wall 55, forming a sealed cup-like structure. Thehousing 52 may be molded in a single piece from a plastic, such aspolypropylene or styrene, or other suitable material. Chamber 53contains a disinfectant that may be carried in a liquid-absorbing matrix(not shown). A lid 70 is sealed across the distal opening of chamber 53.Lid 70 comprises a low permeability material such as aluminum foil andis sealed to housing 52 to form a vapor and liquid barrier to preventleakage or evaporation of the disinfectant liquid that is contained inchamber 53. The lid 70 is further configured to overhang the edge ofhousing 52 or, alternately, have a tab that projects beyond the rim ofhousing 52 such that the lid 70 can easily be peeled off the housing 52.Lid 70 may also have a second tab or flap (not shown) that is foldedover and bonded to the external surface of the circumferential side wall55 such that the lid 70 is not detached from the housing 52 after thelid 70 is peeled away from the distal edge of the circumferential sidewall 55, avoiding the creation of a separate piece of trash. It shall beappreciated by those skilled in the art in view of the subjectdisclosure that a sealing mechanism other than the peelable lid, such asa snap-fit cover, may be employed without departing from the scope ofthe subject disclosure. An elongated finger 58 is located within chamber53 and, in this example, having a height such that the tip of theelongated finger is within the chamber 53 so that lid 70 is not incontact with finger 58.

FIG. 7 illustrates a disinfecting and pre-opening device configured toincorporate a Luer cap according to certain aspects of the presentdisclosure. In this example, the housing 52 further includes a secondchamber 74 and a neck 76 sized and configured to engage the threads 34of male Luer connector 30. In certain embodiments, device 50 is attachedto the male Luer connector 30 as delivered to the user and is thereforeassured of being at hand at the time of use. In certain embodiments,device 50 incorporates a sealing layer 78 which seals against Luer tip32. This configuration is advantageous in that it protects the interiorof male Luer connector 30 from contamination prior to use. In certainembodiments, sealing layer 78 may comprise an absorbent material and adisinfectant. Alternate configurations adapted for connection to othertypes of connectors in this same manner will be apparent to those ofordinary skill in the art without departing from the scope of thesubject disclosure.

FIGS. 8A-8D depict an example sequence of use of a disinfecting andpre-opening device according to certain aspects of the presentdisclosure. FIG. 8A illustrates a syringe 80 having a device 50,including a peelable lid 70, attached to the male Luer connector 30. Thedevice 50 is the embodiment depicted in FIG. 7. This is representativeof how a syringe may be delivered and stocked in a care unit. Othertypes of fluid containers, infusion sets, tubing, etc. may besubstituted in place of the syringe. FIG. 8B illustrates the first stepof entirely removing the lid 70 at the time to connect syringe 30 to afemale Luer connector 40. An alternate process would be to only peelback lid 70 without detaching lid 70 from device 50. FIG. 8C illustratesdevice 50 connected to female Luer connector 30 with matrix 56 incontact with septum 44 and finger 58 penetrating through slit 46. FIG.8D shows the final step wherein the device 50 has been detached fromfemale Luer connector 40 and then removed from syringe 80 and discarded.The male Luer connector 30 of syringe 80 has now been connected tofemale Luer connector 30 with a fluid path established from syringe 80to the container attached to female Luer connector 40.

FIG. 9 is a flow chart that illustrates an example method of using adisinfecting and pre-opening device according to certain aspects of thepresent disclosure. This example is drawn to a scenario having a nursewho wishes to administer a medical fluid to a patient using a syringe tointroduce the fluid to an intravenous set having an access port having aneedleless female Luer connector having a pre-slit septum. Starting atstep 100, the nurse selects a syringe having a male Luer connector withan attached disinfecting and pre-opening device of the type illustratedin FIG. 8A and, in step 105, fills the syringe with the medical fluid.Alternately, the nurse could fill a syringe and collect a separatedisinfecting and pre-opening device. In step 110, the nurse removes thelid from the disinfecting and pre-opening device, exposing thedisinfectant-filled matrix and the pre-opening finger. In step 115, thenurse attaches the disinfecting and pre-opening device to the femaleLuer connector of, in this example, the access port of the IV set andtightens the disinfecting and pre-opening device onto the female Luerconnector until the disinfectant-filled matrix comes into contact withthe septum and the finger penetrates the slit. The nurse then, in step120, detaches the disinfecting and pre-opening device from the femaleLuer connector and also removes the disinfecting and pre-opening devicefrom the syringe and discards the disinfecting and pre-opening device.The nurse then attached the male Luer connector of the syringe to thefemale Luer connector of the access port as described in step 125. Thiscompletes the process, indicated by step 130, and the system isconfigured to administer the medical fluid to the patient.

In summary, a disinfecting and pre-opening device has been disclosedthat is suitable for use with female Luer connectors having a pre-slitseptum. The device applies a disinfectant to the exposed surface of afemale needleless connector and pre-opens the slit in the septum. Theapplication of a disinfectant reduces the chance of a bacteria or othermicrobe being carried by the fluid passing through the female Luerconnector into the bloodstream of a patient. The pre-opening of the slitreduces the chance of a male Luer connector not properly mating with thefemale Luer connector due to cross-linking of the septum across the slitor a lack of lubrication within the slit. As resolution of a problem inmating Luer connectors may require replacement of the entire IV set,which introduces a risk of infection, both the application ofdisinfectant and the pre-opening of the slit increase the safety of thepatient by reducing the chance of infection. Additionally, thedisinfecting and pre-opening device is in a convenient sealed packagethat can be carried by the nurse or provided as an attachment to thesyringe or other item having a male Luer connector, reducing the chancethat the nurse will not have the proper supplies at hand to sterilizethe female Luer connector.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. While theforegoing has described what are considered to be the best mode and/orother examples, it is understood that various modifications to theseaspects will be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, wherein reference to an element in the singular is not intendedto mean “one and only one” unless specifically so stated, but rather“one or more.” Unless specifically stated otherwise, the term “some”refers to one or more. Pronouns in the masculine (e.g., his) include thefeminine and neuter gender (e.g., her and its) and vice versa. Headingsand subheadings, if any, are used for convenience only and do not limitthe invention.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

The term “slit” is used to indicate a separation of a flexible barrierthat allows an elongated element to pass through the flexible barrier bywidening the separation generally without further cutting or puncture ofthe flexible barrier. In some cases, the slit may not traverse theentire thickness of the flexible barrier, with the remaining portion ofthe thickness left intact to present a complete seal prior to the firstinsertion of an elongated element. The two sides of the slit may be inintimate contact and form a liquid-tight seal when the slit is in anundeformed condition. The slit may be a single linear cut, in plan view,or may have a more complex form such as two cuts in the form of an “X”or a plurality of cuts on a common center at angles to each other.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations. Aphrase such as an aspect may refer to one or more aspects and viceversa. A phrase such as an “embodiment” does not imply that suchembodiment is essential to the subject technology or that suchembodiment applies to all configurations of the subject technology. Adisclosure relating to an embodiment may apply to all embodiments, orone or more embodiments. A phrase such an embodiment may refer to one ormore embodiments and vice versa.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. §112, sixth paragraph, unless theelement is expressly recited using the phrase “means for” or, in thecase of a method claim, the element is recited using the phrase “stepfor.” Furthermore, to the extent that the term “include,” “have,” or thelike is used in the description or the claims, such term is intended tobe inclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

Concepts

This writing has disclosed at least the following concepts.

-   Concept 1. A device for use with a female needleless connector    having a proximal end, comprising:

a housing comprising a chamber having a proximal wall, a continuous sidewall coupled to the proximal wall, and a distal opening that isconfigured to fit over the proximal end of the female needlelessconnector;

a fluid-absorbing matrix disposed within the chamber;

a disinfectant disposed within the fluid-absorbing matrix;

a solid elongated finger attached to the proximal wall of the housingand disposed within the chamber such that the elongated finger opens thefluid path through the female needleless connector when the distalopening of the housing is placed adjacent to the proximal end of thefemale needleless connector and the device is advanced in the distaldirection; and

a lining on a portion of an internal surface of the chamber andconfigured to create a removable interference fit with an externalsurface of the female needleless connector.

-   Concept 2. The device of Concept 1, wherein: the female needleless    connector comprises a septum located at the proximal end of the    female needleless connector, the septum having a pre-cut slit; and

the elongated finger substantially penetrates the septum through thepre-cut slit when the distal opening of the device is placed proximallyadjacent to the septum and the device is advanced in the distaldirection.

-   Concept 3. The device of Concept 1, wherein: the female needleless    connector comprises a piston that is surrounded by a housing; and

the elongated finger displaces the piston relative to the housing whenthe distal opening of the device is placed adjacent to the proximal endof the female needleless connector and the device is advanced in thedistal direction.

-   Concept 4. The device of Concept 1, further comprising a vapor    barrier lid removably sealed across the distal opening of the    chamber.-   Concept 5. The device of Concept 4, wherein the portion of the    chamber sealed by the vapor barrier lid is sterile.-   Concept 6. The device of Concept 1, wherein the matrix is disposed    on a proximal wall of the chamber.-   Concept 7. The device of Concept 6, wherein the matrix is further    disposed on a portion of a sidewall adjacent to the proximal wall of    the chamber.-   Concept 8. The device of Concept 6, wherein the matrix is further    disposed on a portion of the elongated finger.-   Concept 9. The device of Concept 1, wherein the housing further    comprises a second chamber and a neck that is sized and configured    to removably couple to a male needleless connector.-   Concept 10. The device of Concept 1, wherein the female needleless    connector comprises a housing and an external thread formed on an    external circumferential surface of the housing, and the device    further comprising a thread formed on an internal surface of the    chamber and configured to engage the external thread of the female    needleless connector.-   Concept 11. The device of Concept 1, wherein the female needleless    connector is a Luer fitting.-   Concept 12. A device for use with a female needleless connector    having a proximal end, comprising:

a housing comprising (i) a first chamber having a proximal wall, acontinuous side wall coupled to the proximal wall, and a distal openingthat is configured to fit over the proximal end of the female needlelessconnector, and (ii) a second chamber and a neck that is sized andconfigured to removably couple to a male needleless connector;

a fluid-absorbing matrix disposed within the first chamber;

a disinfectant disposed within the fluid-absorbing matrix;

a solid elongated finger attached to the proximal wall of the housingand disposed within the first chamber such that the elongated fingeropens the fluid path through the female needleless connector when thedistal opening of the housing is placed adjacent to the proximal end ofthe female needleless connector and the device is advanced in the distaldirection.

-   Concept 13. The device of Concept 12, wherein: the female needleless    connector comprises a septum located at the proximal end of the    female needleless connector, the septum having a pre-cut slit; and

the elongated finger substantially penetrates the septum through thepre-cut slit when the distal opening of the device is placed proximallyadjacent to the septum and the device is advanced in the distaldirection.

-   Concept 14. The device of Concept 12, wherein: the female needleless    connector comprises a piston that is surrounded by a housing; and

the elongated finger displaces the piston relative to the housing whenthe distal opening of the device is placed adjacent to the proximal endof the female needleless connector and the device is advanced in thedistal direction.

-   Concept 15. The device of claim 12, further comprising a vapor    barrier lid removably sealed across the distal opening of the    chamber.-   Concept 16. The device of Concept 15, wherein the portion of the    chamber sealed by the vapor barrier lid is sterile.-   Concept 17. The device of Concept 12, wherein the matrix is disposed    on a proximal wall of the chamber.-   Concept 18. The device of Concept 17, wherein the matrix is further    disposed on a portion of a sidewall adjacent to the proximal wall of    the chamber.-   Concept 19. The device of Concept 17, wherein the matrix is further    disposed on a portion of the elongated finger.-   Concept 20. The device of Concept 12, wherein the female needleless    connector comprises a housing and an external thread formed on an    external circumferential surface of the housing, and the device    further comprising a thread formed on an internal surface of the    chamber and configured to engage the external thread of the female    needleless connector.-   Concept 21. The device of Concept 12, further comprising a lining on    a portion of an internal surface of the chamber and configured to    create a removable interference fit with an external surface of the    female needleless connector.-   Concept 22. The device of Concept 12, wherein the female needleless    connector is a Luer fitting.

What is claimed is:
 1. A device for use with a female needlelessconnector, the device comprising: a housing comprising a chamber havinga proximal wall, a side-wall extending from the proximal wall toward adistal opening configured to fit over a proximal end of the femaleneedleless connector, and an elongate finger extending within thechamber from the proximal wall toward the distal opening, wherein theside-wall extends beyond a distal end of the elongate finger such thatthe elongate finger extends into and opens a fluid path through thefemale needleless connector when the distal opening is distally advancedover the female needleless connector.
 2. The device of claim 1, whereinthe distal end of the elongate finger comprises a rounded outer surface.3. The device of claim 1, wherein an outer surface of the elongatefinger comprises an undercut that extends from the proximal wall towardthe distal end of the elongate finger.
 4. The device of claim 1, whereinan inner surface of the side-wall comprises a portion of afluid-absorbing matrix that contains a disinfectant.
 5. The device ofclaim 1, wherein an outer surface of the elongate finger comprises aportion of a fluid-absorbing matrix that contains a disinfectant.
 6. Thedevice of claim 1, wherein an inner surface of the proximal wallcomprises a portion of a fluid-absorbing matrix that contains adisinfectant.
 7. The device of claim 1, wherein a portion of an innersurface of the side-wall comprises a lining configured to create aremovable interference fit with an external surface of the femaleneedleless connector.
 8. The device of claim 1, comprising a vaporbarrier lid removably sealed across the distal opening of the chamber.9. The device of claim 1, wherein the side-wall tapers toward theproximal wall.
 10. The device of claim 1, wherein the housing comprisesa second chamber and a neck extending from the proximal wall in adirection opposite the side-wall, wherein the neck is sized andconfigured to removably couple to a male needleless connector.
 11. Thedevice of claim 10, wherein a sealing layer is positioned adjacent theproximal wall within the second chamber.
 12. A method of disinfectingand pre-opening a female needleless connector comprising: placing adistal opening of a housing adjacent to a proximal end of a femaleneedleless connector, wherein the housing comprises a chamber having aproximal wall, a side-wall extending from the proximal wall toward thedistal opening, a matrix containing a disinfectant, and an elongatefinger extending within the chamber from the proximal wall toward thedistal opening, wherein the side-wall extends beyond a distal end of theelongate finger; moving the housing in a distal direction such that theside-wall extends over a proximal end of the female needlelessconnector; and advancing the housing in the distal direction such thatthe matrix contacts a septum of the female needleless connector and theelongated finger opens a fluid path through the female needlelessconnector.
 13. The method of claim 12, comprising retracting the housingin a proximal direction to remove the housing from the female needlelessconnector.
 14. The method of claim 12, comprising removing a portion ofa lid that is removably sealed across the distal opening.
 15. The methodof claim 12, comprising removing the housing from a male needlelessconnector.